Human Research Protection Program (HRPP)

The University of Florida (UF) is committed to protecting the rights and welfare of participants involved in human research. This institutional mission is led by UF’s Human Research Protection Program (HRPP) which provides oversight, administrative support and educational training to ensure that UF complies with all applicable federal, state, and local regulations / requirements.

UF’s HRPP is not a specific office, rather it consists of multiple components and is lead by the Office of Research. The primary components of the HRPP are:

Institutional Leadership

Institutional Review Boards

Division of Research Compliance

Division of Sponsored Programs

Investigators & Research Staff

Various Other Institutional Committees, Units and Offices

UF is committed to protecting research participants, upholding ethical standards, and improving our practice at every step. Individuals conducting, supporting or reviewing human research studies should familiarize themselves with all applicable policies. In order to protect participants and stay compliant, all individuals involved in human research should regularly review policies, procedures and guidelines since they are constantly evolving.

For Research Participants

This section is designed to assist former, current, or prospective human research participants in obtaining information or offering input regarding research and clinical trials. It provides important contact information for questions and concerns about participation in research as well as a printable brochure.

Community and Research Participant Feedback Form

Community and Research Participant Feedback

The University of Florida values and appreciates our community, including anyone who volunteers to participate in research. To that end we welcome any suggestions or information from our community and research participants that could further contribute to research initiatives or improve our Human Research Protection Program.

The University of Florida values and appreciates our community, including anyone who volunteers to participate in research. To that end we welcome any suggestions or information from our community and research participants that could further contribute to research initiatives or improve our Human Research Protection Program.

Please share your suggestion or information below:*

You may choose to submit your comments above anonymously. However, if you are willing to provide your name and contact information this will allow us to contact you if we have any questions or follow up for you.

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Human Research Protection Program (HRPP) Accreditation

In order to demonstrate our commitment to the highest standards in human research participant protections, the University of Florida has applied for accreditation of our Human Research Protection Program (HRPP), including the University’s 3 Institutional Review Boards (IRBs). The accrediting agency is the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP)

***** UPDATE – 1/30/18 *****

UF Human Research Protection Program is one step closer to being awarded AAHRPP Accreditation. On January 12th, the AAHRPP Site Visit Review Team concluded its preliminary observations of the University of Florida Human Research Protection program. The three-day site visit, conducted under the direction of UF Office of Research, included an extensive record reviews and more than 70 interviews with various constituents of UF’s HRPP.

It was apparent from the site team’s concluding comments that UF has an exemplary program committed to protecting human research subjects. One site visitor reflected on UF’s commitment to creating a service-oriented culture in the context of an intergrade HRPP, while another praised the support and educational services provided by UF’s CTSI.

Of the three domains and more than 75 elements in the accreditation standards, the site review team found only a dozen or so minor observations to which we are in the process of resolving.

Some of the issues that were identified will require us to educate or update the research community. Please pay careful attention to special announcements from the IRB or other compliance offices. For example, two important announcements were sent earlier last week addressing AAHRPP’s concerns about researchers not understanding certain issues:

Please make every attempt to review these notices and all associated policies, guidelines and guidances documents referenced. Additional educational opportunities, IRB Brown Bag sessions related to both topics — are forthcoming.

Lastly, thank you to all those who have been involved in the undertaking of this initiative. The quality of our HRPP and success of this site visit can be attributed to the dedication of all those committed to UF’s culture of compliance and to the quality of research and protection of our research participants exhibited by the UF research community on a daily basis.

Information About AAHRPP

AAHRPP is a nonprofit association, founded in 2001, that offers accreditation to institutions engaged in human research. AAHRPP seeks to ensure regulatory compliance, promote practices and identify quality protection programs. AAHRPP’s mission is to work “to protect the rights and welfare of research participants and promote scientifically meritorious and ethically sound research by fostering and advancing the ethical and professional conduct of persons and organizations that engage in research with human participants. AAHRPP achieves its mission by using an accreditation process based on self-assessment, peer review, and education.

The AAHRPP website contains a number of useful documents such as information on AAHRPP’s history and formation, its approach to evaluation, and standards for accrediting human research protection programs.

The Accreditation Process

AAHRPP has designed an accreditation process to help organizations consistently meet ethical principles and standards for protecting research participants. The accreditation process includes two major phases: preparation of a written application addressing each of the AAHRPP accreditation standards and a site visit by a team of professionals assembled by AAHRPP to inspect program operations.

While preparing its written application, the Office of Research conducted a lengthy self-assessment of its operations, including the operations of the UF IRBs, to assure that they complied with AAHRPP’s accreditation standards, federal regulations and federal guidance applicable to human research protections. As a result of this review, the Office of Research as created a new HRPP webpage that includes institutional policies related to our human research protection program. Additionally, all 3 UF IRBs now have one cohesive set of polices, regulatory guidances and Investigator guidelines.

The written application to AAHRPP was approved in September 2017. The second phase of AAHRPP accreditation, the site visit, is scheduled for January 10-12, 2018, and will coordinated by the Office of Research. Within 30 days of the site visit, AAHRPP will provide the University with a written evaluation of its findings. We will then have 30 days to respond to these written comments. The written application, site visit findings, and response to the AAHRPP report are then reviewed by AAHRPP’s Council on Accreditation. The Council then determines whether the institution is granted one of the following statuses: full accreditation, qualified accreditation, accreditation withheld, or accreditation-pending. Full or qualified accreditation is granted for 3 years.

Know Your Resources!

It is important to remember that the protection of human subjects is a SHARED responsibility and we are pursuing accreditation Together! The Office of Research has developed a new Human Research Protection Program (HRPP) website that provides important information about our program, including new institutional HRPP Policies. In addition, the UF IRBS have drafted a series of Investigator Guidelines that compliments their recently revised polices and regulatory guidances, to better assist the UF research community in the protection of human subjects.

If you have any questions regarding UF’s HRPP and/or AAHRPP accreditation, please contact Gailine McCaslin in the Office of Research at (352) 273-3407 or gailinemccaslin@ufl.edu.

AAHRPP Site Visit Frequently Asked Questions

Why is AAHRPP Accreditation important to UF?

As one of the leading public research institution in the nation, the University of Florida is committed to excellence in human subject protection. AAHRPP accreditation will not only validated how well we share the responsibility of protecting the rights and welfare of human research participants, but also demonstrates our desire to hold ourselves to a higher set of standards than required by federal and state law. Additionally, it is important to note that not only has UF’s Vice President for Research mandated the institution’s pursuit of this accreditation, but accreditation is also an obligation for State Cancer Center of Excellence Funding.

What happens during the site visit?

The site visit team will meet with senior leadership and key members of the HRPP to ask some organizational-based questions and conduct a record review. They then conduct interviews IRB chairs, IRB members, staff, and chairs, as well as investigators and research study team members. They also interview key institutional officials, such as those who review contracts, manage financial conflicts of interest, lead departments involved in research, and provide legal advice.

How will people be selected for interviews?

The AAHRPP team will select people to be interviewed from the HRPP Personnel list provided during the accreditation application process Investigators will be selected who reflect the ranges of experience, protocol volume, types of ongoing research, and research risk levels at the organization. In addition to investigators, site visitors will interview coordinators, co-investigators, and other study team members.

If selected, we will provide you with additional prep reparation to promote a successful interview.

What is AAHRPP looking for during the Site Visit?

AAHARP is interested in your awareness of and knowledge about key concepts and policies, including, but not limited to:

Human subject research regulations such as the Common Rule (45 CFR 46), FDA regulations, the Belmont Report, and Conflict of Interest policies

Human subject protections and the procedures you use to implement them such as elements of informed consent, strategies for minimizing risk, adverse event and unanticipated problems

The strength, cohesiveness and effectiveness of the HRPP, including education and training, adequacy of resources for researchers, researcher accountability, HRPP structure, and perceptions of the HRPP

NOTE: The specific questions you will be asked by the AAHRPP site visitors depends upon your role within the UF HRPP.